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Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy

NCT ID: NCT05680584

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-01-30

Brief Summary

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Comparison between the effect of oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in pediatric Patients Undergoing Adenotonsillectomy

Detailed Description

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The aim of the study is to compare the effectiveness of preoperative oral melatonin and hydroxyzine on preoperative anxiety in pediatric patients undergoing adenotonsillectomy.

The primary outcomes:

1. Ease of parenteral separation.
2. The compliance to anesthesia induction in pediatric patients.

The secondary outcomes:

1. Assessment of postoperative pain.
2. Time to first analgesic request.

Conditions

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Effect of Drug Anxiety

Keywords

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Melatonin Hydroxyzine Preoperative Anxiety Pediatric Adenotonsillectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three study groups
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Melatonin

Preoperative oral melatonin 0.1mg/ kg in 10ml apple juice one hour before induction of anesthesia

Group Type ACTIVE_COMPARATOR

Melatonin 3 MG

Intervention Type DRUG

0.1 mg/ kg melatonin in 10 ml apple juice 1 hour before induction of anesthesia

Hydroxyzine

Preoperative oral hydroxyzine 1mg/ kg in 10ml apple juice one hour before induction of anesthesia

Group Type ACTIVE_COMPARATOR

Hydroxyzine Pill

Intervention Type DRUG

1 mg/ kg hydroxyzine in 10 ml apple juice 1 hour before induction of anesthesia

placebo

10ml apple juice one hour before induction of anesthesia

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

10 ml apple juice 1 hour before induction of anesthesia

Interventions

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Melatonin 3 MG

0.1 mg/ kg melatonin in 10 ml apple juice 1 hour before induction of anesthesia

Intervention Type DRUG

Hydroxyzine Pill

1 mg/ kg hydroxyzine in 10 ml apple juice 1 hour before induction of anesthesia

Intervention Type DRUG

Placebo

10 ml apple juice 1 hour before induction of anesthesia

Intervention Type OTHER

Other Intervention Names

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Melatonin Atarax 10mg

Eligibility Criteria

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Inclusion Criteria

1. ASA: class l
2. Sex: male and female
3. Age: from 3 to 10 years old
4. Children scheduled for adenotonsillectomy

Exclusion Criteria

1. All children with a history of chronic illness, or developmental delay were excluded from the study
2. History of an autoimmune disease
3. Concurrent use of immunosuppressive treatment
4. Sleep disturbances, speech or communication problems
5. allergic to hydroxyzine, cetirizine, or other derivatives of piperazine, aminophylline, and ethylenediamine.
6. hydroxyzine is contraindicated in patients with acute porphyria

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Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Sarah Mohamed Aly Omar Mousa

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah Omar

Role: STUDY_DIRECTOR

Minia University

Locations

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Sarah Omar

Al Minyā, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sarah Omar, M.D.

Role: CONTACT

Phone: +20100537617

Email: [email protected]

Hanafy

Role: CONTACT

Facility Contacts

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Sarah Omar

Role: primary

Other Identifiers

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505/2022

Identifier Type: -

Identifier Source: org_study_id